Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.

2015-000956-29

Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.

2016-10-19

2021-11-09

2031-08-01

Active (not recruiting)

Early phase I

132

Inclusion Criteria: * Patients older than 18 years of age * Informed consent * Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank * Chronic hemodialysis * Affiliated to a social security system Exclusion Criteria: * Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine) * Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone) * Peritoneal dialysis * Preemptive transplantation * Hypersensitivity or known allergy to Eplerenone or one of its excipients * Patients with severe hepatic insufficiency (class Child-Pugh C) * Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone) * Hypersensitivity or known allergy to iodinated contrast agents (iohexol) * Demonstrated thyrotoxicosis * Hypersensitivity to lactose * HLA desensitization prior to renal transplantation * Pregnant woman or woman without effective contraception * Patient under judicial protection * Patient under legal guardianship * Participation in another biomedical study

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2023-06-18